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Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is a leading clinical-stage biopharmaceutical company specializing in the development of innovative therapies for immuno-inflammatory diseases. Founded by dermatologists, Aclaris leverages its extensive expertise in dermatologic treatments to address significant unmet needs in both medical and aesthetic dermatology.
Aclaris operates primarily through two segments: therapeutics and contract research. The therapeutics segment focuses on identifying and developing novel therapies to treat immuno-inflammatory diseases. Key drug candidates in this segment include Zunsemetinib, an oral MK2 inhibitor, ATI-2138, an ITJ inhibitor, and ATI-1777, a topical JAK 1/3 inhibitor. The contract research segment generates revenue by offering laboratory services, which constitute a significant portion of the company’s revenue.
Recent milestones for Aclaris include the progression of ATI-2138 into Phase 2a proof-of-concept trials for T cell-mediated autoimmune diseases and the completion of enrollment for the ATI-1777 Phase 2b trial in atopic dermatitis. Preliminary data from these trials have shown promising results, paving the way for further clinical development. Aclaris has also announced partnerships with institutions like Washington University to explore additional therapeutic applications for its drug candidates.
Financially, Aclaris maintains a robust liquidity position. As of the end of 2023, the company holds approximately $181.9 million in cash, cash equivalents, and marketable securities, ensuring the capability to fund operations through 2025. Revenue generation is primarily driven by contract research services and strategic licensing agreements, such as the recent deal with Sun Pharmaceutical Industries, Inc., which grants exclusive rights under certain patents for the use of deuruxolitinib in treating alopecia areata and androgenetic alopecia.
Aclaris Therapeutics (NASDAQ: ACRS) announced a new publication highlighting the properties of ATI-2138, their novel investigational covalent inhibitor of ITK and JAK3 for treating autoimmune and inflammatory diseases. The drug demonstrates potent and selective blocking of both ITK and JAK3, effectively inhibiting key T cells involved in conditions like atopic dermatitis, alopecia areata, and vitiligo.
The publication details ATI-2138's performance in biochemical target inhibition, cellular systems, and animal models. Key findings show the drug's unique pharmacological profile with high potency in inhibiting both ITK and JAK3. In initial clinical trials, ATI-2138 was generally well-tolerated, with no serious adverse events reported. The drug showed dose- and time-dependent modulation of biomarkers linked to both ITK and JAK3 activity in healthy participants.
Aclaris Therapeutics (NASDAQ: ACRS) has announced the formation of a new Scientific Advisory Board (SAB) focused on pulmonology expertise. The initial board includes two distinguished members: Dr. Marianne Mann, a pulmonologist with over 30 years of experience in regulatory science and former FDA Deputy Director, and Dr. Zuzana Diamant, a renowned pulmonologist and clinical pharmacologist.
Dr. Mann brings extensive experience in clinical trial design and regulatory strategy from her roles at the FDA and NIH. Dr. Diamant, a guest professor at KU Leuven and past-chair of multiple respiratory medicine organizations, has co-authored over 200 peer-reviewed publications and brings expertise in drug development and clinical studies for respiratory diseases.
The SAB will guide Aclaris's development programs for immuno-inflammatory diseases, leveraging the members' combined expertise in respiratory medicine, clinical pharmacology, and immunology.
Aclaris Therapeutics (NASDAQ: ACRS) has announced inducement grants under NASDAQ Listing Rule 5635(c)(4). The company's Compensation Committee granted 215,000 nonstatutory stock options and 61,000 restricted stock units to one new employee under their 2024 Inducement Plan.
The stock options have an exercise price of $2.48 per share, matching Aclaris' common stock closing price on January 2, 2025. Both the options and restricted stock units will vest in four equal annual installments of 25% each, starting from the grant date, contingent on continued employment. These equity awards were granted as material inducements for the new employee joining Aclaris, in compliance with NASDAQ rules.
Aclaris Therapeutics (NASDAQ: ACRS) announced new employee equity grants under its 2024 Inducement Plan. The company granted nonstatutory stock options to purchase 251,000 shares and 73,000 restricted stock units to 4 new employees. Additionally, Hugh Davis, Ph.D, the new President and Chief Operating Officer, received options to purchase 375,000 shares and 107,000 restricted stock units.
The options have an exercise price of $3.96 per share, matching the closing price on December 2, 2024. Both options and restricted stock units will vest 25% annually over four years, contingent on continued employment. These grants were made as employment inducements in accordance with NASDAQ Listing Rule 5635(c)(4).
Aclaris Therapeutics (NASDAQ: ACRS), a clinical-stage biopharmaceutical company specializing in immuno-inflammatory disease treatments, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's management team will engage in a fireside chat on Tuesday, December 3, 2024, at 1:00 PM ET in New York.
Interested parties can access the webcast through the 'Events' page in the 'Investors' section of Aclaris' website. The recording will remain available for a minimum of 30 days on www.aclaristx.com.
Biosion has entered into an exclusive license agreement with Aclaris Therapeutics (NASDAQ: ACRS) for worldwide rights (excluding Greater China) to two immunology assets: BSI-045B and BSI-502. The deal includes an upfront payment of over $40 million, 19.9% of Aclaris common stock, and potential milestone payments exceeding $900M with tiered royalties.
BSI-045B, a clinical-stage anti-TSLP antibody, has shown promising results in a Phase 2a trial for atopic dermatitis with 22 patients. BSI-502 is a pre-clinical stage bispecific antibody targeting both TSLP and IL4R. The agreement grants Aclaris development and commercialization rights worldwide, except for Greater China.
Aclaris Therapeutics (NASDAQ: ACRS) has secured an exclusive global license agreement with Biosion for worldwide rights (excluding Greater China) to two key biologics: BSI-045B, a clinical-stage anti-TSLP monoclonal antibody, and BSI-502, a pre-clinical stage bispecific antibody targeting TSLP and IL4R. BSI-045B has shown promising results in a Phase 2a trial for atopic dermatitis with 22 patients. The company also announced the appointment of two new executives: Hugh Davis as President and COO, and Steven Knapp as EVP, Head of Regulatory & Quality. The agreement strengthens Aclaris' pipeline in immunology with both small and large molecule drugs.
Aclaris Therapeutics (NASDAQ: ACRS) has secured a $80 million private placement through the sale of 35,555,555 shares of common stock at $2.25 per share. The placement was led by Vivo Capital, with participation from both new and existing investors including Forge Life Science Partners, Rock Springs Capital, and RA Capital Management, among others. The transaction is expected to close around November 19, 2024. The proceeds will be used to fund research and development of the company's pipeline and general corporate purposes. The company has agreed to file a registration statement with the SEC for the resale of the shares.
Aclaris Therapeutics (NASDAQ: ACRS) reported Q3 2024 financial results with a net loss of $7.6 million, improved from $29.3 million in Q3 2023. Revenue decreased to $4.3 million from $9.3 million year-over-year. The company maintains a strong cash position of $173.4 million, expected to fund operations into 2028.
Key developments include the first patient dosed in the ATI-2138 Phase 2a trial for atopic dermatitis, with top-line data expected in H1 2025. R&D expenses decreased to $6.0 million from $23.9 million, while G&A expenses reduced to $5.7 million from $7.1 million in the prior year period.
Aclaris Therapeutics (NASDAQ: ACRS) has announced the dosing of the first patient in its Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of ITK and JAK3, for treating moderate to severe atopic dermatitis. The open-label study aims to evaluate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 over a 12-week period.
The trial plans to enroll approximately 15 subjects in the United States, with primary endpoints focusing on safety-related parameters. Secondary endpoints include EASI response measures, vIGA response, and BSA response. Aclaris expects to release topline data from this trial in the first half of 2025.
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